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| Name | Class |
|---|---|
| ClÃnica Vespucio, Santiago, Chile | UNKNOWN |
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We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.
In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection.
Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients.
If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Salbutamol is diluted in hypertonic (3%) saline. |
|
| 2 | Active Comparator | Salbutamol is diluted in normal (0.9%) saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation of salbutamol diluted in hypertonic saline | Drug | The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the respiratory distress score (Tal) between the basal score and the first nebulization | 15 to 20 minutes | |
| Change in the respiratory distress score (Tal) between the basal score and the second nebulization | 15 to 20 minutes after the first nebulization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irmeli Roine, MD, PhD | Contact | +56-2-6762916 | irmeli.roine@prof.udp.cl | |
| Ricardo Mercado, MD | Contact | +56-9-3320792 | rmercado@ssmso.cl |
| Name | Affiliation | Role |
|---|---|---|
| Irmeli Roine, MD, PhD | University Diego Portales | Principal Investigator |
| Ricardo Mercado, MD | Clinica Vespucio, Santiago, Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Vespucio | Recruiting | Santiago | 00300 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12475841 | Background | Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015. | |
| 12576370 | Background | Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481. |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
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|
| Inhalation of salbutamol diluted in normal saline | Drug | The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline. |
|
|
| Change in pulse oxymetry reading between the basal score and after each of the three nebulizations | 1 hour |
| Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization | 1 hour |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007552 |
| Isotonic Solutions |